Nutritional Supplementation in Sarcopenic Obesity

Sarcopenic Obesity Clinical Trial

— SARCO  

Official title:

Effectiveness of a Rehabilitation Program (Nutritional + Physical Activity) in Sarcopenic Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05143398
• Other study ID #: 2018_06_28_05
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: March 10, 2021

Study information

• Verified date: November 2021
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The obese patient presents a quantitative and qualitative deficit of muscle mass as occurs in the elderly subject that was named Sarcopenic Obesity (SO). The use of a diet that includes protein supplements and / or essential amino acids seems to improve this condition in the elderly; there are no similar studies in obese subjects, in particular during a low-calorie diet and physical activity program that can produce further loss of muscle mass. This study aims to verify whether the administration of these supplements (protein or amino acid) in the obese patient are effective in improving anthropometric and functional parameters and some serum markers of muscle metabolism. The results obtained could represent new therapeutic protocols in the treatment of obesity.

Description:

Several studies have confirmed that adequate nutrition, especially protein intake, including at breakfast, or supplementation with amino acids, in association with adequate physical activity plays an important role in the treatment of SO.

The supplementation of protein or amino acid preparations (in particular with the 9 essential amino acids including, the branched - leucine, isoleucine, valine), marketed in different formulations, has already allowed to document a significant therapeutic efficacy in the treatment of elderly sarcopenic subjects. In fact, the use of these preparations improves physical performance and muscle strength by inducing the synthesis of proteins involved in the biogenesis and functionality of mitochondria - that is, the cellular organelles responsible for the production of energy in the form of ATP - and of myofibrillar proteins (which constitute the large percentage of muscle mass), both in laboratory animals and in humans.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 10, 2021
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients with obesity (BMI> 35kg / m2)

• sarcopenia (criteria described in Coltorti A et al).

Exclusion Criteria:

• renal insufficiency

• diabetes

• muscular pathologies

• neurological-neurodegenerative pathologies

• cognitive decline

Related Conditions & MeSH terms

• Obesity
• Sarcopenic Obesity

Intervention

Dietary Supplement:
• Diet + protein
Comparison of the efficacy
• Diet + EAA
Comparison of the efficacy
• Diet + EAA and TCA
Comparison of the efficacy

Other:
• Diet
Comparison of the efficacy

Locations

Country	Name	City	State
Italy	Amelia Brunani	Verbania	VB

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

References & Publications (9)

Coltorti A, Scalfi L, Borrelli R, Contaldo F, Diaz E. [Validity of 5 bioelectric impedance equations for the estimation of lean body mass in women]. Minerva Endocrinol. 1991 Jan-Mar;16(1):37-41. Italian. — View Citation

D'Antona G, Ragni M, Cardile A, Tedesco L, Dossena M, Bruttini F, Caliaro F, Corsetti G, Bottinelli R, Carruba MO, Valerio A, Nisoli E. Branched-chain amino acid supplementation promotes survival and supports cardiac and skeletal muscle mitochondrial biogenesis in middle-aged mice. Cell Metab. 2010 Oct 6;12(4):362-372. doi: 10.1016/j.cmet.2010.08.016. — View Citation

Frimel TN, Sinacore DR, Villareal DT. Exercise attenuates the weight-loss-induced reduction in muscle mass in frail obese older adults. Med Sci Sports Exerc. 2008 Jul;40(7):1213-9. doi: 10.1249/MSS.0b013e31816a85ce. — View Citation

Hsu KJ, Liao CD, Tsai MW, Chen CN. Effects of Exercise and Nutritional Intervention on Body Composition, Metabolic Health, and Physical Performance in Adults with Sarcopenic Obesity: A Meta-Analysis. Nutrients. 2019 Sep 9;11(9). pii: E2163. doi: 10.3390/nu11092163. Review. — View Citation

Malafarina V, Uriz-Otano F, Malafarina C, Martinez JA, Zulet MA. Effectiveness of nutritional supplementation on sarcopenia and recovery in hip fracture patients. A multi-centre randomized trial. Maturitas. 2017 Jul;101:42-50. doi: 10.1016/j.maturitas.2017.04.010. Epub 2017 Apr 22. — View Citation

Rondanelli M, Opizzi A, Antoniello N, Boschi F, Iadarola P, Pasini E, Aquilani R, Dioguardi FS. Effect of essential amino acid supplementation on quality of life, amino acid profile and strength in institutionalized elderly patients. Clin Nutr. 2011 Oct;30(5):571-7. doi: 10.1016/j.clnu.2011.04.005. Epub 2011 Jun 1. — View Citation

Solerte SB, Gazzaruso C, Bonacasa R, Rondanelli M, Zamboni M, Basso C, Locatelli E, Schifino N, Giustina A, Fioravanti M. Nutritional supplements with oral amino acid mixtures increases whole-body lean mass and insulin sensitivity in elderly subjects with sarcopenia. Am J Cardiol. 2008 Jun 2;101(11A):69E-77E. doi: 10.1016/j.amjcard.2008.03.004. — View Citation

Valerio A, D'Antona G, Nisoli E. Branched-chain amino acids, mitochondrial biogenesis, and healthspan: an evolutionary perspective. Aging (Albany NY). 2011 May;3(5):464-78. Review. — View Citation

Wang X, Miller GD, Messier SP, Nicklas BJ. Knee strength maintained despite loss of lean body mass during weight loss in older obese adults with knee osteoarthritis. J Gerontol A Biol Sci Med Sci. 2007 Aug;62(8):866-71. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Body weight	weight in kilograms	basal and at 4 weeks
Primary	Change of Height	height in meters	basal and at 4 weeks
Primary	Change of BMI	weight and height will be combined to report BMI in kg/m^2	basal and at 4 weeks
Primary	Change of Waist	waist circumference in centimeters	basal and at 4 weeks
Primary	Change of FM	Fat Mass (FM) in % of body weight in kilograms	basal and at 4 weeks
Primary	Change of FFM	Free Fat Mass (FFM) in % of body weight in kilograms	basal and at 4 weeks
Primary	Change of MM	Muscle Mass (MM) in % of body weight in kilograms	basal and at 4 weeks
Primary	Change of Muscle strenght	muscle streght at the hand (right and left) in kg	basal and at 4 weeks
Primary	Change of Walking	6 minute walk test (6MWT), meters walking in 6 minutes	basal and at 4 weeks
Primary	Change of TUG	time, in second, to up from the chair, walks 3 meters, turns around, walks back to the chair and sits down	basal and at 4 weeks
Primary	Change of Metabolic profile	glycaemia, total cholesterol, LDL cholesterol, triglycerides all in mg/dl	basal and at 4 weeks
Primary	Change of Insulin secretion	insulin pasma levels in mU/l	basal and at 4 weeks
Primary	Change of Homa index	glycaemia and insulin will be combined to report Homa index in mmol/l/mU/l	basal and at 4 weeks
Primary	Change of Muscle function	irisin and procollagen type III N-terminal peptide (P3NP) in ng/ml	basal and at 4 weeks
Primary	Change of Muscle wasting	C-terminal agrin fragment (CAF) in pg/ml	basal and at 4 weeks